Country regulatory profiles
Identical structure across 41 markets, authorities, MA pathways, fees, timelines, MAH/RP requirements, post-approval lifecycle. Every figure is sourced.
MARKETS41PROFILES VERIFIED17/41FEES CONFIRMED85/150PATHWAYS INDEXED150RELIANCE PATHWAYS34ICH MEMBER STATES31ENGLISH SUBMISSIONS31SOURCESAUTHORITY LINKED
MARKETS41PROFILES VERIFIED17/41FEES CONFIRMED85/150PATHWAYS INDEXED150RELIANCE PATHWAYS34ICH MEMBER STATES31ENGLISH SUBMISSIONS31SOURCESAUTHORITY LINKED
For RPs, QPs, RA & QA teams
Every market. Every pathway. One structured reference.
Authority cited profiles for 41 markets. The only structured database of unlicensed pathways.
41Markets
150Pathways
34Reliance routes
§ 01 · Capabilities
Unlicensed medicine pathway database
Named patient supply, compassionate use, and emergency import, with legal basis, approval authority, documentation, and timeline. The only structured database of its kind.
Side-by-side country comparison
Benchmark timelines, fees, reliance pathways, and local-presence requirements across up to three markets. Replaces the spreadsheet you've been maintaining.
§ 02 · A profile, dissected
See for yourself
A profile you can interrogate, not just read
Every page is structured the same way: authority, pathways, fees, timelines, MAH and RP requirements, post-approval, supply chain, pricing. Every figure is linked to its primary source, and every profile states the date it was last verified and by whom.
- Linked sources at section level, never a free-floating claim.
- Tracks fee revisions, pathway changes, and lifecycle reform.
- Named contributor on every page, full credentials disclosed.
🇬🇧
UpdatedUnited Kingdom
MHRA · Europe
IRP timeline
60 to 110 days
IRP fee
£35,305
English subs
Accepted
eCTD
v3.2.2 / v4
Reliance
8 reference agencies
Local rep
Not required (IRP)
Sources
MHRA International Recognition Procedure (Jan 2024) · MHRA fees 2025 to 2027 · MHRA Submissions portal v3.1 spec.
§ 03 · Coverage
41 markets, identical structure
From the FDA to PMDA, side-by-side comparable.
§ 04 · Editorial standards
Editorial standards
Built like a regulatory publication, not a SaaS dashboard
Authority publications first. Named contributors with disclosed conflicts of interest. A stated verification date on every profile, and every claim linked to its primary source.
Stated verification date
Each profile says when it was last checked against the regulator, and says plainly when it has not been checked since it was compiled.
Authority linked sources
Authority publications first. Consultancy and academic sources only ever as triangulation.
Named contributors
Every profile carries a contributor name and credentials. We do not anonymise authorship.
| Criterion | 🇬🇧 UK | 🇪🇺 EU | 🇺🇸 US |
|---|---|---|---|
| Lead pathway | IRPIRP | Centralised | NDANDA |
| Approval (days) | 60 to 110 | 210 | 180 to 360 |
| English subs | Yes | Yes | Yes |
| Local rep | Not required | MAHMAH in EU/EEA | US agent |
| Reliance | 8 agencies | - | - |
| HTAHTA | NICENICE/SMCSMC | Member-state | - |
Lead pathway
- 🇬🇧 UKIRPIRP
- 🇪🇺 EUCentralised
- 🇺🇸 USNDANDA
Approval (days)
- 🇬🇧 UK60 to 110
- 🇪🇺 EU210
- 🇺🇸 US180 to 360
English subs
- 🇬🇧 UKYes
- 🇪🇺 EUYes
- 🇺🇸 USYes
Local rep
- 🇬🇧 UKNot required
- 🇪🇺 EUMAHMAH in EU/EEA
- 🇺🇸 USUS agent
Reliance
- 🇬🇧 UK8 agencies
- 🇪🇺 EU-
- 🇺🇸 US-
HTAHTA
- 🇬🇧 UKNICENICE/SMCSMC
- 🇪🇺 EUMember-state
- 🇺🇸 US-
Stop maintaining the spreadsheet
Side-by-side comparison across markets
Pick two or three countries. Get every criterion an RPRP or QPQP actually files against, timelines, fees, MAHMAH residency, local responsible person, GMPGMP inspection, accelerated pathways, post-approval framework, HTAHTA. Save the view, share it.
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Stop second-guessing the regulatory map
Country profiles you can interrogate. Pathways you can compare. An assistant grounded in the same source-cited dataset.